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Research ArticleOriginal Research

Teratogen Use in Women of Childbearing Potential: An Intervention Study

Karie A. Morrical-Kline, Alison M. Walton and Tracey M. Guildenbecher
The Journal of the American Board of Family Medicine May 2011, 24 (3) 262-271; DOI: https://doi.org/10.3122/jabfm.2011.03.100198
Karie A. Morrical-Kline
PharmD
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Alison M. Walton
PharmD, BCPS
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Tracey M. Guildenbecher
MD
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  • Article
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Article Figures & Data

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  • Figure 1.
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    Figure 1.

    Patient inclusion and exclusion.

  • Figure 2.
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    Figure 2.

    Patient characteristics affecting risk documentation.

Tables

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    Table 1.

    Food and Drug Administration (FDA) Pregnancy Category Definitions8

    FDA Pregnancy CategoryDefinition
    AControlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimesters), and the possibility of fetal harm seems to be remote.
    BEither animal reproductive studies have not demonstrated a fetal risk but there are no controlled studies of pregnant women, or animal reproductive studies have shown adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk during later trimesters).
    CEither studies in animals have revealed adverse effects on the fetus (teratogenic or embrocidal or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
    DThere is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
    XStudies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
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    Table 2.

    Survey Administered to Physicians Before and After Educational Initiative

    Survey QuestionSurvey ResponseCorrect response Before Intervention (n = 36) (n [%])Correct response After Intervention (n = 38) (n [%])P
    1. Which pregnancy drug category are ACE-I and ARB in?a. A15 (41.7)22 (57.9).176
    b. B
    c. C*
    d. D*
    e. X
    f. I don’t know
    2. Which pregnancy drug category is statin in?a. A10 (27.8)19 (50)<.065
    b. B
    c. C
    d. D
    e. X*
    f. I don’t know
    3. ACE-I and ARB primarily affect which fetal system if exposed during the second and third trimester?a. Lung23 (63.9)28 (73.7).440
    b. Cardiovascular
    c. Renal*
    d. Nervous
    e. I am unsure
    4. There is increasing evidence that ACE-I/ARB have adverse effects to fetuses exposed during the first trimester.a. True*19 (52.8)33 (86.8).650
    b. False
    c. I am not sure
    5. Statin has been shown to adversely affect fetal development in human studies.a. True7 (19.4)9 (23.7).652
    b. False*
    c. I am not sure
    6. In the past several months have you prescribed an ACE-I, ARB, or statin to any women between the ages of 15 to 45?a. Yes†8 (22.2)10 (26.3)1.000
    b. No
    c. I’m not sure
    7. When prescribing ACE-I, ARB, or statin, do you consider the possibility of the patients becoming pregnant while taking the drug?a. Yes, always†24 (66.7)31 (81.6).678
    b. Usually†
    c. Sometimes
    d. No, never
    8. If you do consider possible pregnancy when prescribing ACE-I/ARB and statin, do you make an effort to document use of contraception and discussion of possible risks?a. Yes, always†25 (69.4)28 (73.7).091
    b. Usually†
    c. Sometimes
    d. No, never
    e. I don’t consider pregnancy risk when prescribing
    Physician Demographics
    9. Gendera. Male19 (52.85)17 (44.7).316
    b. Female17 (47.2)21 (55.3)
    10. Current year of residency traininga. PGY-116 (44.4)18 (47.4).889
    b. PGY-211 (30.6)10 (26.3)
    c. PGY-38 (22.2)9 (23.7)
    d. PGY-42 (5.6)1 (2.6)
    11. Current residency training programa. FM13 (36.1)12 (31.6).770
    b. IM5 (13.9)8 (21.1)
    c. FM/IM5 (13.9)3 (7.9)
    d. OB/GYN9 (25.0)8 (21.1)
    e. Transitional3 (8.3)7 (18.4)
    • ↵* Correct response to survey question.

    • ↵† Considered preferred answers.

    • ACE-I, angiotensin-converting enzyme inhibitors; ARB, angiotensin receptor blockers; statin, HMG-CoA reductase inhibitors; PGY, postgraduate year; IM, internal medicine; FM, family medicine; OB/GYN, obstetrics/gynecology.

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    Table 3.

    Patient and Physician Demographics

    CharacteristicsBefore Intervention (n = 200) (n [%])After Intervention (n = 131) (n [%])P
    Patient
        Age (years).728
            15 to 40 years old124 (62.0)84 (64.1)
            41 to 45 years old76 (38.0)47 (35.9)
        Medication prescribed
            ACE-I129 (64.5)95 (72.5).149
            ARB29 (14.5)17 (13.0).747
            Statin88 (44.0)50 (38.2).307
        Disease state indication
            HTN154 (77.0)109 (83.2).211
            DM88 (44.0)62 (47.3).574
            HLD90 (45.0)56 (42.7).735
        Use of contraception*44 (22.0)38 (29.0).154
        Pregnancy test at prescription5 (2.5)4 (3.1).744
    Physician
        Resident training program.176
            IM102 (51.0)59 (45.0)
            FM54 (27.2)37 (28.2)
            IM/FM combined program7 (3.5)9 (6.9)
            OB/GYN5 (2.5)0 (0)
            Faculty32 (16.0)26 (19.8)
        PGY of Training<.001
            PGY10 (0)15 (11.5)
            PGY238 (19)39 (29.8)
            PGY360 (30.0)43 (32.8)
            Graduate 200960 (30.0)3 (2.3)
            Faculty35 (17.5)31 (23.7)
            Graduate7 (3.5)0 (0)
    • ↵* Method of contraception not different between treatment groups.

    • ACE-I, angiotensin-converting enzyme inhibitors; ARB, angiotensin receptor blockers; statin, HMG-CoA reductase inhibitors; HTN, hypertension; DM, diabetes; HLD, hyperlipidemia; IM, Internal Medicine; FM, Family Medicine; OB/GYN, Obstetrics/Gynecology; PGY, postgraduate year.

    • View popup
    Table 4.

    Primary Outcome Measures

    Before Intervention (n = 200) (n [%])After Intervention (n = 131) (n [%])P
    Frequency of targeted medications prescribed
        ACE-I129 (64.5)95 (72.5).149
        ARB29 (14.5)17 (13.0).747
        Statin88 (44.0)50 (38.2).307
    Frequency of risk documentation40 (20)49 (37.4)<.001
    • ACE-I, angiotensin-converting enzyme inhibitors; ARB, angiotensin receptor blockers; Statin, HMG-CoA reductase inhibitors.

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The Journal of the American Board of Family Medicine: 24 (3)
The Journal of the American Board of Family Medicine
Vol. 24, Issue 3
May-June 2011
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Teratogen Use in Women of Childbearing Potential: An Intervention Study
Karie A. Morrical-Kline, Alison M. Walton, Tracey M. Guildenbecher
The Journal of the American Board of Family Medicine May 2011, 24 (3) 262-271; DOI: 10.3122/jabfm.2011.03.100198

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Teratogen Use in Women of Childbearing Potential: An Intervention Study
Karie A. Morrical-Kline, Alison M. Walton, Tracey M. Guildenbecher
The Journal of the American Board of Family Medicine May 2011, 24 (3) 262-271; DOI: 10.3122/jabfm.2011.03.100198
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